Principal Scientist, Clinical Pharmacology & Pharmacometrics

Position Overview

The Principal Scientist, Clinical Pharmacology and Pharmacometrics will bring extensive experience in oncology quantitative pharmacology, clinical pharmacology strategy, and oncology drug development.   

Responsibilities

• Formulate and deliver CP&MS strategy for late-stage and early preclinical/clinical development assets.  

• Apply pharmacokinetic/pharmacodynamics (PK/PD), physiologic based PK (PBPK) and pharmacometric modeling & simulation (M&S) approaches to characterize drug absorption and disposition and assess the dynamics of drug effect to inform dose selection and go/no-go decisions.  

• Work with preclinical and clinical CROs and company scientists to conduct and monitor clinical pharmacology studies, maintain study records and ensure study completion along program timelines.  

• Contribute and drive program strategy, study design, protocol preparation, study execution, data review/analysis, report preparation and regulatory document preparation.  

Qualifications

• Ph.D. or PharmD in a relevant scientific discipline (clinical pharmacology, pharmacometrics or closely related scientific discipline)  

• 2-5 years' experience in pharmaceutical/biotechnology industry in a regulated bioanalytical environment, preferably with multiple modalities, including small molecule, large molecule and ADC experience.  

• Experience in noncompartmental and PBPK analyses and pharmacometric modeling and simulation oversight including use of WINNONLIN, NONMEM, MONOLIX or similar statistical modeling software  

• Knowledge of R, R-shiny, SAS, MATLAB, NONMEM, MONOLIX, PBPK (gastroplus or Simcyp) or similar modeling software and substantial experience integrating quantitative clinical pharmacology with oncology drug development strategy  

• Familiarity with current global clinical pharmacology and pharmacometrics regulatory guidance.  

• Experience in development of anti-cancer agents, preferably ADCs and/or RLTs.  

Knowledge and Skills

• Excellent written/oral communication, interpersonal and problem-solving skills.  

• Experience in oncology drug development with small and large molecule clinical pharmacology strategy. Experience in translational aspects of drug discovery and development is strongly preferred.  

• Ability to deliver integrated clinical pharmacology roadmap to registration and new product label.  

• Can manage multiple project related workstreams simultaneously under tight timelines collaboratively.  

• Experience managing clinical pharmacology related data transfers, analysis, reporting, and related timelines.  

• Experience interacting with global health authorities on optimal dosage design and clinical pharmacology strategy.  Effective forms of written and spoken communication is essential (eg clinical pharmacology protocols, pharmacokinetic/pharmacometric reports and regulatory submissions and performing quality control).  

• Knowledge of regulatory requirements governing drug development.  

• Resourcefulness, pragmatism, creativity, and an independent work ethic.